Transcorneal Electrical Stimulation Therapy for Retinal Disease

Okuvision

Status: Completed

Conditions: Macula Off; Retinal Artery Occlusion; Non-Arthritic-Anterior-Ischemic Optic-Neuropathy; Treated Retina Detachment; Ischemic Macula Edema; Dry Age Related Macular Degeneration; Hereditary Autosomal Dominant Optic Atrophy; Primary Open Angle Glaucoma; Retinal Vein Occlusion; Retinitis Pigmentosa; Hereditary Macular Degeneration

Treatments: Device: DTL-electrode attached without energy; Device: Transcorneal Electrical Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804102

EST-2008

Details and patient eligibility

About

Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Exclusion criteria

• Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
• Age above 99 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 12 patient groups

Retinitis pigmentosa

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Macula off

Active Comparator group

Description:

condition after treatment of retinal detachment

Treatment:

Device: Transcorneal Electrical Stimulation

Primary open angle Glaucoma

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Hereditary Macular Degeneration

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Treated Retina detachment

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Retinal Artery Occlusion

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Retinal Vein Occlusion

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Hereditary autosomal dominant Optic atrophy

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

dry Age-related Macular Degeneration

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Ischemic Macula edema

Active Comparator group

Treatment:

Device: Transcorneal Electrical Stimulation

Non-stimulated

Sham Comparator group

Treatment:

Device: DTL-electrode attached without energy